NA 27302 (UDI 00763000406080)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00763000406080), received between Sep 14, 2022 and Aug 29, 2024 — classified as 4 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (10 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2024Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT WHEN THE NURSING STAFF ATTEMPTED TO EMPTY THE CEREBROSPINAL FLUID (CSF) FROM THE CHAMBER, THE SYSTEM WAS UNDER NO "PRESSURE" WHEN THE DRIP CHAMBER "CRACKED OPEN." THE DEVICE WAS REPLACED. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20095166 ↗
• InjuryJun 20, 2024Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH THE MAIN COMPLAINT OF "BLURRED VISION IN BOTH EYES FOR MORE THAN 2 YEARS AND PAROXYSMAL HEADACHE FOR MORE THAN 1 YEAR". ON (B)(6) 2024, THE PATIENT WAS SENT TO THE OPERATING ROOM FOR "TRANSSPHENOIDAL APPROACH SELLAR SKULL BASE TUMOR RESECTION UNDER NEURONAVIGATION + NEUROENDOSCOPY-ASSISTED VENTRICULAR CHOROID PLEXUS CAUTERIZATION + OPTIC NERVE DECOMPRESSION + SELLAR DURA MATER REPAIR + RIGHT THIGH FASCIA LATA RESECTION" UNDER GENERAL ANESTHESIA WITH TRACHEAL INTUBATION. IN ORDER TO PREVENT CEREBROSPINAL FLUID LEAKAGE DURING OPERATION, LUMBAR EXTERNAL DRAINAGE AND MONITORING SYSTEM WAS RETAINED. ON THE EVENING OF JUNE 9,2024, WHEN THE NURSE WAS PATROLLING THE WARD TO CHECK THE PIPELINE, IT WAS FOUND THAT THE DRESSING AT THE LUMBAR CISTERN WAS LOOSE, AND THERE WAS CEREBROSPINAL FLUID LEAKAGE. AFTER INSPECTION, IT WAS FOUND THAT THE DRAINAGE TUBE WAS BROKEN AT 15 CM OF THE OUTER PIPELINE OF THE SKIN PUNCTURE OUTLET, THE DRESSING COVERING THE PUNCTURE OUTLET WAS MOIST, AND THE NURSING PAD PLACED ON THE LUMBAR SACRAL REGION HAD OBVIOUS S

  Patient problems: Malaise

  MAUDE report 19577155 ↗
• MalfunctionMar 7, 2024Infusion or Flow Problem; Migration; Infusion or Flow Problem; Migration

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024 DUE TO SUDDEN RIGHT LIMB WEAKNESS AND WAS DIAGNOSED WITH INTRAVENTRICULAR HEMORRHAGE. IN ORDER TO FURTHER DRAIN THE BLOODY CEREBROSPINAL FLUID, THE PATIENT UNDERWENT LUMBAR DRAINAGE UNDER LOCAL ANESTHESIA ON (B)(6) 2024. POOR DRAINAGE OCCURRED AT ON (B)(6) 2024. WHEN CHANGING THE DRESSING ON THE WOUND, IT WAS DISCOVERED THAT THE LUMBAR DRAINAGE TUBE CAME OUT. IT WAS NOTED THAT THE PATIENT'S BODY MAY HAVE TWISTED, AND THE DRAINAGE TUBE SLIPPED. ON (B)(6) 2024, THE LUMBAR DRAINAGE TUBE WAS REMOVED AT THE BEDSIDE. OBSERVING THE PATIENT'S CONDITION, NO MAJOR CHANGES IN THE PATIENT'S CONDITION WERE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18855259 ↗
• MalfunctionFeb 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT AFTER THE PATIENT WAS IMPLANTED, IT WAS FOUND THAT THE PART CONNECTING THE LUMBAR END CATHETER AND THE CONNECTING CATHETER WERE LEAKING. THE LEAKAGE WAS IMPROVED AFTER CLINICALLY ADDING A TEE IN THE MIDDLE. THE CLINICIANS BELIEVED THAT THE LEAKAGE WAS CAUSED BY THE FAILURE OF THE LUMBAR END CATHETER AND THE CONNECTING CATHETER CONNECTOR TO COMPLETELY CLOSE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. THE PATIENT'S MEDICAL HISTORY WAS CEREBROVASCULAR DISEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18649865 ↗
• MalfunctionFeb 5, 2024Complete Blockage; Complete Blockage

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE SYSTEM. IT WAS REPORTED THAT THERE WAS A BLOCKAGE OF THE EXTERNAL LUMBAR DRAINAGE TUBE. THE HEALTH CARE PROFESSIONAL DISCOVERED THAT THE TUBE WAS BLOCKED DURING THE IMPLANTATION PROCESS. THEREFORE, ANOTHER EXTERNAL LUMBAR DRAINAGE AND MONITORING SYSTEM OF THE SAME TYPE WAS REPLACED. AFTER USING IT, THE OPERATION WENT SMOOTHLY. NO REPORTED IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639320 ↗
• MalfunctionJan 31, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT WHEN IMPLANTING THE DEVICE, THE PACKAGE WAS OPENED AND FOUND UNKNOWN STAINS/FOREIGN OBJECTS INSIDE. THE DEVICE WAS REPLACED. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18615897 ↗
• MalfunctionJan 25, 2024Break; Fracture; Infusion or Flow Problem; Break; Fracture; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE PATIENT SUFFERED FROM HYDROCEPHALUS AND INTRAVENTRICULAR HEMORRHAGE. ON (B)(6) 2023, THE DOCTOR PERFORMED A BEDSIDE LUMBAR PUNCTURE AND INSERTED A LUMBAR DRAINAGE DEVICE. AFTER THE TUBE WAS INSERTED, THE DRAINAGE WAS NOT SMOOTH. THE DRAINAGE TUBE WAS WITHDRAWN AND WAS PLANNED TO BE RE-PLACED. DURING INSERTION, IT WAS FOUND THAT THE TUBE BODY WAS TORN AND PARTIALLY LOST NEAR THE TAIL END OF THE DRAINAGE CATHETER, AND THE OPERATION WAS IMMEDIATELY STOPPED FOR OBSERVATION. THE PERSON IN CHARGE OF THE DEPARTMENT LATER ANALYZED THAT PART OF THE REASON WAS THE POSITION OF THE PATIENT'S SPINE, AND PART OF IT WAS THAT THE PRODUCT TUBE BODY WAS NOT TOUGH ENOUGH AND TEARS OCCURRED DURING INSTALLATION. SINCE IT WAS DISCOVERED IN TIME, NO HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580940 ↗
• MalfunctionDec 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT WHEN IMPLANTING THE LUMBAR SEGMENT, AN ADAPTER WAS NEEDED. WHEN THE JOINT WAS INSTALLED, IT WAS FOUND THAT THE JOINT WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18310390 ↗
• MalfunctionSep 22, 2023Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM BEING USED FOR A RUPTURED ANEURYSM BLEEDING AND INTRAVENTRICULAR HEMORRHAGE. ON (B)(6), 2023, THE CONNECTION SITE OF THE LUMBAR EXTERNAL DRAINAGE TUBE FELL OFF AFTER THE PATIENT TURNED OVER. THERE WAS A SMALL AMOUNT OF EXTRAVASATION OF DRAINAGE FLUID. AFTER NOTIFYING THE DOCTOR ON DUTY TO DISCUSS THE CONDITION, THE DRAINAGE TUBE WAS REMOVED, AND THE PATIENT'S CONDITION WAS OBSERVED. A CT SCAN WAS PERFORMED THE NEXT DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17798687 ↗
• MalfunctionSep 5, 2023Break; Fracture; Break; Fracture

  THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2023 DUE TO "RIGHT MIDDLE CEREBRAL ANEURYSM RUPTURE WITH SUBARACHNOID HEMORRHAGE". AFTER ANEURYSM EMBOLIZATION, LUMBAR PUNCTURE + LUMBAR CISTERN DRAINAGE WERE PERFORMED, AND ON (B)(6), THE DRAINAGE TUBE OF THE LUMBAR EXTERNAL DRAINAGE AND MONITORING SYSTEM WAS BLOCKED, AND THE SYRINGE FLUSHING WAS BLOCKED, RESULTING IN POOR BLOOD DRAINAGE IN THE SUBARACHNOID SPACE OF THE PATIENT, AND IT WAS UNABLE TO EFFECTIVELY PURIFY THE CEREBROSPINAL FLUID, WHICH MAY CAUSE COMPLICATIONS. THE DRAINAGE TUBE WAS REMOVED, AND A LUMBAR PUNCTURE WAS CONSIDERED AS APPROPRIATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682616 ↗
• MalfunctionSep 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. AFTER THE PATIENT UNDERWENT LUMBAR PUNCTURE IN THE AFTERNOON OF (B)(6) 2023, THE PRODUCT WAS USED FOR EXTERNAL LUMBAR DRAINAGE AND DETECTION, AND ABOUT 5 HOURS LATER, THE DRAINAGE BOTTLE LEAKED. IT WAS REPORTED THAT DUE TO TIMELY NOTIFICATION, THE DOCTOR WAS ABLE TO TAKE MEASURES WHEN THE PRODUCT PROBLEM WAS FOUND, AND NO IMPACT ON THE PATIENT 4. TREATMENT MEASURES AND RESULTS TAKEN: THE DOCTOR DISINFECTED AND CLAMPED THE DRAINAGE TUBE TO STOP THE FLOW, REPLACE WITH A NEW PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17670200 ↗
• InjuryJul 28, 2023Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR PUNCTURE AND DRAINAGE AS DIRECTED BY THE DOCTOR DUE TO A LARGE NUMBER OF HEMORRHAGES IN THE VENTRICLES. DURING THE OPERATION, THE EXTERNAL LUMBAR DRAINAGE AND MONITORING SYSTEM WERE USED. THE DRAINAGE DEVICE FOUND THAT THE DRAINAGE BOTTLE AND THE DRAINAGE BAG CONNECTOR WERE DETACHED, RESULTING IN UNCLEAR DRAINAGE VOLUME. AFTER IT WAS FOUND, THE DRAINAGE TUBE WAS PULLED OUT IMMEDIATELY, AND NO HARM WAS CAUSED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17413306 ↗
• InjuryJul 28, 2023Break; Fracture; Break; Fracture

  THE SYSTEM WAS REMOVED, AND LUMBAR EXTERNAL DRAINAGE WAS NO LONGER PERFORMED. THE DEVICE WAS IMPLANTED FOR 10 DAYS. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. THE ISSUE WAS LIKELY DUE TO PATIENT MOVEMENT DURING BED REST, IMPROPER USE OF STRAIN RELIEF, ETC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17412740 ↗
• MalfunctionJul 17, 2023Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. ON (B)(6) 2023, THE PATIENT UNDERWENT "INTRACRANIAL SPACE-OCCUPYING LESION RESECTION" UNDER GENERAL ANESTHESIA DUE TO INTRACRANIAL SPACE-OCCUPYING LESIONS. DRAINAGE OF CEREBROSPINAL FLUID BY PLACING EXTERNAL LUMBAR DRAINAGE AND DETECTION SYSTEM DURING OPERATION. AFTER THE OPERATION, THE PATIENT WAS TREATED IN THE WARD OF DEPARTMENT OF NO.1 NEUROSURGERY, AND THE CONNECTION OF THE PATIENT'S DRAINAGE DEVICE FELL OFF BY ITSELF, RESULTING IN POLLUTION AND UNUSABLE, AND THE DRAINAGE DEVICE WAS REMOVED. THE PATIENT'S VITAL SIGNS WERE STABLE DURING THE EVENT. THE POTENTIAL CAUSES OF THE EVENT WERE AS FOLLOWS. 1. IT WAS SUSPECTED THAT THE PRODUCT QUALITY FACTOR CAUSED THIS ADVERSE EVENT; 2. IT WAS NOT RULED OUT THAT THE MEDICAL STAFF¿S IMPROPER OPERATION CAUSED THIS ADVERSE EVENT; 3. CONSIDERING THAT THE PATIENT¿S BODY POSITION MOVEMENT CAUSED THIS ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17334915 ↗
• InjuryJul 13, 2023Break; Fracture; Infusion or Flow Problem; Break; Fracture; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THE ANTERIOR SEGMENT OF THE CATHETER RUPTURED, AND INSERTION WAS DIFFICULT. THE PATIENT UNDERWENT LUMBAR CISTERN DRAINAGE UNDER LOCAL ANESTHESIA ON (B)(6) 2023. TOOK THE RIGHT SIDE CHEST AND KNEE POSITION. TOOK THE INTERSECTION OF THE LINE CONNECTING THE POSTERIOR SUPERIOR ILIAC SPINE AND THE POSTERIOR MIDLINE AS THE PUNCTURE POINT. THE INTERSECTION OF THE CONNECTING LINE OF THE POSTERIOR SUPERIOR ILIAC SPINE AND THE POSTERIOR MIDLINE WAS TAKEN AS THE PUNCTURE POINT. CONVENTIONAL DISINFECTION TOWEL LAYING. AFTER 2% LIDOCAINE WAS ANESTHETIZED LAYER BY LAYER, PUNCTURE NEEDLE WAS USED INSTEAD. BLOODY CEREBROSPINAL FLUID FLOWED OUT AFTER SUCCESSFUL PUNCTURE. DIFFICULTY IN IMPLANTING DRAINAGE CATHETER, REPEATED ADJUSTMENTS, INSERTION OF CATHETER. AFTER REMOVING THE CATHETER, CONNECTED THE DRAINAGE DEVICE. CHECKED THE PATENCY OF THE CATHETER, NO CEREBROSPINAL FLUID FLOW OUT OF THE CATHETER. THE CATHETER WAS CHECKED, THE PUNCTURE CATHETER WAS PULLED OUT, AND IT WAS PLANNED TO BE REINSERTED, BUT THE ANTERIOR SEGMENT OF THE CATHETER WAS BROKEN. PUNCTURE AGAIN, AFTER SUCCESSFUL PUNCTURE, CATHETER PLACEMENT WAS STILL DI

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17321279 ↗
• MalfunctionJul 13, 2023Disconnection; Disconnection

  THE PATIENT'S CONDITION WAS STABLE AFTER THE REPLACEMENT OF DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17316553 ↗
• MalfunctionJul 7, 2023Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. THE PATIENT HAD EXTERNAL LUMBAR DRAINAGE AND MONITORING SYSTEM PLACED ON (B)(6) AND LUMBAR CISTERN DRAINAGE WAS PERFORMED TO DRAIN CEREBROSPINAL FLUID. ON (B)(6) IT WAS FOUND THAT THE TEE JOINT OF THE DRAINAGE TUBE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17278716 ↗
• MalfunctionJul 5, 2023Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT WHEN THE CATHETER WAS READY FOR SURGICAL IMPLANTATION, THERE WAS A LEAK AND DAMAGE AT THE REAR END. THE PRODUCT WAS REPLACED AND THE ISSUE WAS RESOLVED. THERE WAS A REPORTED DELAY OF 10 MINUTES. NO PARTS WERE LEFT IN THE PATIENT'S BODY. ON (B)(6) 2023, THE PROBLEM OCCURRED AND THE PATIENTWENT TO THE HOSPITAL FOR INSPECTION AND FOUND THAT THERE WAS INDEED A SMALL HOLE LEAKING AT THE BACK END OF THE CATHETER TUBE. RELEVANT MEDICAL HISTORY: RIGHT THALAMIC HEMORRHAGE AND RUPTURE INTO THE VENTRICLE, TRANSIENT CEREBRAL HEMORRHAGE ATTACK, CEREBRAL INFARCTION, HIGH-RISK GROUP OF GRADE III HYPERTENSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17260186 ↗
• MalfunctionJun 30, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A AND EXTERNAL DRAINAGE AND MONITORING DEVICE. IT WAS REPORTED THE CATHETER AT THE ANTI-REFLUX DEVICE OF THE EXTERNAL DRAINAGE OF LUMBAR WAS BROKEN. CSF CAME INTO CONTACT WITH THE AIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239805 ↗
• MalfunctionMay 8, 2023Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING DEVICE. IT WAS REPORTED THAT DURING TUBE PLACEMENT THE FRONT END OF THE TUBE WAS BROKEN AND THE DRAINAGE COULD NOT BE DONE NORMALLY. THE DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED. THERE WAS A DELAY OF 5 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16887080 ↗
• MalfunctionFeb 16, 2023Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM (EDMS) USED DURING AN EXTERNAL LUMBAR DRAINAGE PROCEDURE. IT WAS REPORTED THAT WHEN AN EXTERNAL LUMBAR DRAINAGE SYSTEM WAS PLACED, ANTI-REVERSE FLOW VALVE WAS LEAKING FLUID. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS RUPTURED INTRACRANIAL ANEURYSM WITH SUBARACHNOID HEMORRHAGE. THERE WAS NO ADDITIONAL SURGERY OR TREATMENT PERFORMED AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WAS NO FLUID INFILTRATION. THE LEAK OCCURRED ON THE ANTI-REFLUX VALVE CONNECTED TO THE LUMBAR CATHETER, NOT ABOVE THE DRAINAGE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16389883 ↗
• MalfunctionSep 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A LUMBAR DRAINAGE DEVICE. IT WAS REPORTED THAT THE AFTER THE LUMBAR PUNCTURE, WHEN THE PRODUCT WAS CONNECTED FOR USE, IT WAS FOUND THAT THERE WAS LEAKING AT THE CONNECTOR. THIS WAS A NEW PRODUCT AND THE USER REPORTED THAT THEY BELIEVED THIS WAS A QUALITY PROBLEM AND THEY DID NOT DAMAGE THE DEVICE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS CONFLICTING INFORMATION IN THE FILE. IT WAS REPORTED THAT THE PATIENT WAS BOTH MALE AND FEMALE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417713 ↗